Database updated: 26 February 2024

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:18028
Brand Name:S&N Birmingham Hip Resurfacing (BHR) Head
Model:74121138, 74123140, 74121142, 74123144, 74121146, 74123148, 74121150, 74123152, 74121154, 74123156, 74121158, 74123160, 74123162
Affected:All lots
Software version:
Recalling Organisation:Smith & Nephew Surgical Ltd
Unit A 36 Hillside road
Wairau Valley
AUCKLAND 0760
Contact Information:0800 657 799
Manufacturer:Smith & Nephew Orthopaedics Ltd
Brand Name:S&N Birmingham Hip Resurfacing (BHR) Acetabular Cup
Model:74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122050, 74122152, 74120152, 74120154, 74122154, 74122156, 74120156, 74120158, 74122158, 74122160, 74120160, 74120162, 74122162, 74122164, 74120164, 74120166, 74122166, 74122168
Affected:All lots
Software version:
Recalling Organisation:Smith & Nephew Surgical Ltd
Unit A 36 Hillside road
Wairau Valley
AUCKLAND 0760
Contact Information:0800 657 799
Manufacturer:Smith & Nephew Orthopaedics Ltd
Brand Name:S&N Birmingham Hip Resurfacing (BHR) Dysplasia Cup
Model:74120246, 74122248, 74120250, 74122252, 74120254, 74122256, 74120258, 74122260, 74120262, 74122264, 74120266
Affected:All lots
Software version:
Recalling Organisation:Smith & Nephew Surgical Ltd
Unit A 36 Hillside road
Wairau Valley
AUCKLAND 0760
Contact Information:0800 657 799
Manufacturer:Smith & Nephew Orthopaedics Ltd
Issue:Smith & Nephew has updated the Instructions for Use of the BHR System to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data.
If a patient from the following population sub-groups is implanted with a BHR System, the patient is at greater risk of requiring a revision surgery earlier than expected:
* Females
* Males aged 65 or greater
* Patients requiring an implant head size < 48mm
Patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarges bursae, pain and swelling local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function.
Recall action type:Alert
Recall action:Instructions for use to be updated
Level of recall:Healthcare Professional
Date Commenced:5/2/2015
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